WASHINGTON (May 23, 2018) – The U.S. House gave final approval to federal Right to Try law that will allow terminally ill patients to access investigational treatments that have not received final FDA approval. Passage of this bill was a direct result of action that started in the states five years ago.
The U.S. Senate passed the Right to Try Act of 2017 nine months ago. After stalling for months, the House finally approved the measure Tuesday by a 250-169 vote. Pres. Trump is expected to sign the bill into law.
The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval. RIght to Try allows terminally ill patients to bypass the expanded access provision and obtain experimental drugs from manufacturers without first obtaining FDA approval.
While this may seem like a great victory, Congress was actually quite late to the party. Forty states have already approved Right to Try legislation and pressure bubbling up from the state level drove Congress to act.
Colorado started the ball rolling when Gov. John Hickenlooper signed the first state Right to Try bill into law in May 2014. Over the next four years, the movement to simply ignore the FDA expanded access program and nullify it in effect swept across the nation. The Goldwater Institute was instrumental in starting and driving the Right to Try movement. Instead of trying to get a law passed in D.C., the organization started with the states.
“We were told this was an impossible dream. That the FDA zealously guarded an exclusive power to decide when anyone can try a new medicine. That Washington politicians and federal courts were too heavily invested in promoting the FDA’s authority and would not force the agency to stand down. Our response? The Founding Fathers never viewed the federal government as the only source or protector of our liberties. Under the U.S. Constitution, all 50 states have the authority and the duty to protect your freedom. With your enthusiastic support, we traveled from state capital to state capital to talk about this fundamental principle of healthcare freedom. With your help, we built a grassroots bipartisan coalition of doctors, of healthcare advocates, of patients and their loved ones.”
Right toTry at the state level proved demonstrably successful.
Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in the Lone Star State received an experimental cancer treatment not allowed by the FDA. While the FDA would have allowed these patients to die, Houston-based oncologist Dr. Ebrahim Delpassand continued their treatment through the Texas law. (Watch a video about Dr. Delpassand here.)
The Goldwater Institute credits the willingness of state governments to move forward and pass Right to Try without federal permission as the catalyst that drove change in D.C.
“This national momentum opened Washington’s eyes to what can be accomplished when you work to advance freedom instead of stripping liberty away.”
This once again demonstrates the power of a bottom-up approach. We’ve seen the same thing happen with marijuana. As more and more states have legalized cannabis, the pressure to change federal law has mounted. State and local action drive change in D.C. and we need to replicate this strategy on other issues.
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